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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bristol-Myers Squibb |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00284180 |
This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer
Condition | Intervention | Phase |
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Breast Neoplasms Breast Cancer |
Drug: Vinflunine Drug: Herceptin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Vinflunine Plus Trastuzumab in HER2 Over-Expressing Metastatic Breast Cancer |
Estimated Enrollment: | 96 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks.
If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks.
Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
United States, Alabama | |
Northeast Alabama Regional Medical Center | |
Anniston, Alabama, United States, 36207 | |
United States, Florida | |
Integrated Community Oncology Network | |
Jacksonville, Florida, United States, 32256 | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
Watson Clinic Center for Cancer Care and Research | |
Lakeland, Florida, United States, 33805 | |
United States, Georgia | |
Northeast Georgia Medical Center | |
Gainesville, Georgia, United States, 30501 | |
United States, Louisiana | |
Hematology Oncology Life Center | |
Alexandria, Louisiana, United States, 71301 | |
United States, Michigan | |
Grand Rapids Clinical Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
United States, South Carolina | |
Spartanburg Regional Medical Center | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Tennessee | |
Tennessee Oncology | |
Nashville, Tennessee, United States, 37205 | |
Associates in Hematology Oncology | |
Chattanooga, Tennessee, United States, 37404 |
Principal Investigator: | Denise A Yardley, MD | Sarah Cannon Research Institute |
Responsible Party: | Sarah Cannnon Research Institute ( Denise Yardley, M.D. ) |
Study ID Numbers: | SCRI BRE 89, CA183014 |
Study First Received: | January 27, 2006 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00284180 |
Health Authority: | United States: Food and Drug Administration |
Breast Neoplasms Breast Cancer Vinflunine Vinca Alkaloid Javlor |
Vinca Alkaloids Skin Diseases Trastuzumab Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |